Jin W, Feng L, Hu X S, Wang Z J, Hao X Z, Lin L
Department of Traditional Chinese Medicine, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Zhonghua Yi Xue Za Zhi. 2023 Apr 25;103(16):1196-1201. doi: 10.3760/cma.j.cn112137-20221110-02364.
To observe the clinical efficacy and safety of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) combined with chemotherapy as first-line treatment for EGFR mutant advanced non-small cell lung cancer (NSCLC). It was a retrospective, single-arm real-world study and a total of 39 patients with stage ⅢB to Ⅳ EGFR mutant NSCLC diagnosed in Cancer Hospital of Chinese Academy of Medical Sciences from July 2018 to December 2020 were collected. There were 16 males and 23 females, the age ranged from 25 to 73 years, with a median age of 53 years. All patients received EGFR-TKIs synchronously combined with pemetrexed and platinum-containing chemotherapy for 4-6 cycles as first-line treatment, followed by EGFR-TKI monotherapy with or without pemetrexed maintenance therapy. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and adverse reactions were evaluated. Median follow-up time was 18.6 months (95% 16.2-21.0 months). The Kaplan-Meier method was used for survival analysis. The ORR was 61.5% (24/39), the DCR was 94.9% (37/39) and the median PFS was 16.4 months (95%: 12.1-20.7 months). The main adverse reactions were liver function injury (59.0%, 23/39), myelosuppression (43.6%, 17/39), skin reaction (25.6%, 10/39), gastrointestinal reaction (17.9%, 7/39), fatigue (12.8%, 5/39) and kidney injury (5.1%, 2/39). Most of the patients had grade 1-2 adverse reactions, and the rate of grade 3 adverse events were 12.8%(5/39), which were effectively alleviated after symptomatic support treatment, no grade 4 serious adverse events occurred. EGFR-TKIs synchronously combined with chemotherapy followed by EGFR-TKI monotherapy with or without pemetrexed maintenance therapy has a certain therapeutic effect and fairly good safety, which can prolong PFS in patients with EGFR mutated advanced NSCLC.
观察表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs）联合化疗作为表皮生长因子受体（EGFR）突变的晚期非小细胞肺癌（NSCLC）一线治疗方案的临床疗效及安全性。本研究为回顾性单臂真实世界研究，收集了2018年7月至2020年12月在中国医学科学院肿瘤医院确诊的39例ⅢB至Ⅳ期EGFR突变NSCLC患者。其中男性16例，女性23例，年龄25至73岁，中位年龄53岁。所有患者均接受EGFR-TKIs同步联合培美曲塞及含铂化疗4至6周期作为一线治疗，后续接受EGFR-TKI单药治疗，部分患者联合或不联合培美曲塞维持治疗。评估客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）及不良反应。中位随访时间为18.6个月（95%可信区间16.2至21.0个月）。采用Kaplan-Meier法进行生存分析。ORR为61.5%（24/39），DCR为94.9%（37/39），中位PFS为16.4个月（95%可信区间：12.1至20.7个月）。主要不良反应为肝功能损伤（59.0%，23/39）、骨髓抑制（43.6%，17/39）、皮肤反应（25.6%，10/39）、胃肠道反应（17.9%，7/39）、乏力（12.8%，5/39）及肾损伤（5.1%，2/39）。多数患者不良反应为1至2级，3级不良事件发生率为12.8%（5/39），经对症支持治疗后均有效缓解，未发生4级严重不良事件。EGFR-TKIs同步联合化疗，后续接受EGFR-TKI单药治疗，部分患者联合或不联合培美曲塞维持治疗，对EGFR突变的晚期NSCLC患者有一定治疗效果且安全性较好，可延长患者的PFS。
